FDA Accepts New Drug Application for Duvelisib and Grants Priority Review
Verastem, Inc. (VSTM)
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Source: Business Wire
Application Seeks Full Approval for Duvelisib for the Treatment of Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Accelerated Approval in Relapsed/Refractory Follicular Lymphoma FDA Target Action Date of October 5, 2018 BOSTON--(BUSINESS WIRE)-- Verastem, Inc. (NASDAQ:VSTM), a biopharmaceutical company focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing with Priority Review its New Drug Application (NDA) for its lead product candidate duvelisib. Duvelisib is a first-in-class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, for which Verastem is seeking full approval for the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (C
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Sec Filings
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